Business Regulatory Affairs Specialist
3 days ago
**Job Overview:**
Lifelancer is a leading talent-hiring platform in Life Sciences, Pharma, and IT. We connect top talent with exciting opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.
About the Role:
We are seeking an experienced Business Regulatory Affairs Specialist to join our Life Sciences team. As a key member of our team, you will play a crucial role in ensuring our clients' products comply with current regulations.
Key Responsibilities:
- Collect, collate, and evaluate scientific data gathered as part of R&D
- Advise on legal and scientific restraints and requirements
- Develop regulatory submission strategies
- Author CMC documents and health authority packages
Requirements:
- 7-11 years of experience in Life Sciences (ARD) Services
- MBBS/MD degree
- Strong understanding of strategic direction and team goals
- Excellent analytical and problem-solving skills
About Lifelancer:
Lifelancer is a global professional services company with leading capabilities in digital, cloud, and security. We offer strategy and consulting, technology, and operations services, all powered by the world's largest network of Advanced Technology and Intelligent Operations centers.
What We Offer:
- A competitive salary range of $120,000 - $180,000 per year
- A dynamic and collaborative work environment
-
Regulatory Affairs Specialist
3 weeks ago
Bengaluru, Karnataka, India Baxter Full timeRegulatory Affairs at Baxter: A Key Role in Delivering Innovative Healthcare SolutionsBaxter, a leading medical products company, is seeking a talented Regulatory Affairs Specialist to join its team. In this crucial role, you will play a key part in ensuring the company's products meet the highest regulatory standards, enabling us to deliver innovative...
-
Regulatory Affairs Specialist
2 days ago
Bengaluru, Karnataka, India ScaleneWorks Full timeJob Description Overview:ScaleneWorks seeks a skilled Regulatory Affairs Specialist to lead our regulatory efforts. As a key member of the team, you will be responsible for ensuring the compliance of our products with relevant regulations.About the Role:This is an exciting opportunity to join ScaleneWorks as a Regulatory Affairs Specialist. You will be...
-
Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Baxter Full timeRegulatory Role at BaxterBaxter is a leading company in the healthcare industry, and we are seeking a highly skilled Regulatory Affairs Specialist to join our team. In this role, you will be responsible for providing regulatory support for on-market products, ensuring compliance with regulatory requirements, and identifying opportunities for process...
-
Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Baxter Full timeTransforming Healthcare, One Document at a TimeBaxter is a global leader in medical innovations, and we're looking for a skilled Regulatory Affairs Specialist to join our team.As a Regulatory Affairs Specialist at Baxter, you'll play a critical role in ensuring the accuracy and compliance of regulatory documentation for our medical products.Responsibilities...
-
Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Philips Full timeJob Title: Principal Regulatory Affairs SpecialistJob Description:Key Responsibilities:Develop and execute regulatory strategies for new product development, design changes, and field safety corrections for US, EU, and RoW.Author 510k submissions, lead pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications, and lead...
-
Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Philips Full timeAbout the RolePhilips is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for the US, EU, and RoW.Key...
-
Regulatory Affairs Specialist
1 month ago
Bengaluru, Karnataka, India Baxter Full timeTransforming Healthcare through Regulatory ExcellenceBaxter is a leading medical innovation company that has been pioneering significant medical breakthroughs for over 85 years. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance and quality of our products and therapies.Key Responsibilities:Create and review...
-
Global Biosimilars Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Biocon Biologics Full timeJob Title: Global Biosimilars Regulatory Affairs SpecialistDescription:We are seeking a highly skilled Global Biosimilars Regulatory Affairs Specialist to join our team at Biocon Biologics.As a Global Biosimilars Regulatory Affairs Specialist, you will be accountable for the development and execution of CMC regulatory strategies, marketing applications, and...
-
Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Stryker Global Technology Center Pvt Ltd. Full timeJob Title: Regulatory Affairs Specialist - Clinical EvidenceAbout the Role:We are looking for a highly experienced Regulatory Affairs Specialist to join our team in Stryker Global Technology Center Pvt Ltd. The successful candidate will be responsible for driving the establishment of a coherent Clinical Evidence strategy throughout the new product...
-
Regulatory Affairs Specialist
1 month ago
Bengaluru, Karnataka, India Amazon Kuiper Services India Private Limited - Q38 Full timeJob DescriptionAmazon Kuiper Services India Private Limited - Q38 is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Global Regulatory Affairs team, you will play a critical role in enabling and protecting Kuiper's use of radio frequency spectrum and satellite orbits worldwide.About the RoleThe successful...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Lifelancer Full timeCompany OverviewLifelancer is a leading talent-hiring platform in the Life Sciences, Pharma, and IT sectors. Our mission is to connect top talent with opportunities in these fields. Job Title: Regulatory Affairs ManagerSalary: $120,000 - $180,000 per yearLocation: Remote or On-Site (Flexible)Job Description:We are seeking an experienced Regulatory Affairs...
-
Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Baxter Full timeVantive: Revolutionizing Kidney CareBaxter is transforming its Kidney Care segment into a standalone company, Vantive. This new entity will leverage Baxter's legacy in acute therapies and home and in-center dialysis to deliver best-in-class care to patients worldwide.As a Regulatory Affairs Specialist at Vantive, you will be part of a community driven to...
-
Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Parexel Full timeAbout this role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Parexel. As a key member of our Regulatory Affairs team, you will be responsible for handling the pre and post-approval life cycle management of drug products.Key Responsibilities:Contribute to the preparation and delivery of regulatory maintenance submissions...
-
Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Genpact Full time✅ Job OverviewGenpact is seeking a highly skilled Regulatory Affairs Specialist to join our team.The ideal candidate will possess a strong background in ECTD submissions, publishing systems, and regulatory guidelines.Key ResponsibilitiesPublishing and validating technical submissions (eCTD/CTD/NeeS/Paper) for the LATAM and Canadian regions.Performing final...
-
Regulatory Affairs Specialist: eCTD submissions
4 weeks ago
Bengaluru, Karnataka, India Genpact Full timeAt Genpact, we are seeking a skilled Regulatory Affairs Specialist to join our team. This role demands an experienced publisher with a demonstrated ability to execute responsibility in a highly regulated and process-driven environment.The ideal candidate will have a deep understanding of eCTD types of submissions and industry-standard publishing systems....
-
Director of Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Lifelancer Full time**About Lifelancer**Lifelancer is a global talent-hiring platform that connects professionals with opportunities in the life sciences, pharma, and IT industries. Our goal is to help individuals advance their careers while promoting equal opportunities for people with disabilities. **Company Overview**Lilly is a global healthcare leader headquartered in...
-
Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Parexel Full timeParexel seeks a dedicated Regulatory Affairs Specialist to support the life cycle management of biologic products in regulated and emerging markets.Key Responsibilities:8-9 years of experience in handling pre and post-approval life cycle management of biologic products in various markets (EU/US/Canada) and emerging markets.Good understanding of regulatory...
-
Regulatory Affairs Specialist
1 month ago
Bengaluru, Karnataka, India Parexel Full timeAbout the RoleParexel is seeking a highly skilled Regulatory Affairs professional to join our team. As a Regulatory Affairs Consultant, you will be responsible for managing the pre- and post-approval life cycle of biologic products in various markets, including regulated (EU/US/Canada) and emerging markets.Key ResponsibilitiesDevelop and implement regulatory...
-
Regulatory Affairs Director
2 weeks ago
Bengaluru, Karnataka, India Parexel Full timeDirector of Regulatory Affairs and Clinical TrialsWe are seeking a highly experienced Director to lead our regulatory affairs and clinical trials team.About the RoleThis is a senior leadership position that will oversee the strategic direction of our regulatory affairs and clinical trials operations.Key ResponsibilitiesProvide strategic guidance on...
-
Bengaluru, Karnataka, India Bosch Group Full timeJob Summary:As a Regulatory Affairs Specialist for Product Compliance, you will be responsible for ensuring that our products meet all applicable safety and performance standards. This includes researching and interpreting relevant regulations, standards, and directives, as well as staying updated on changes in regulations and standards.Key...